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Pharmaceutical Products Testing (Microbial Testing under TGO 98)

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Pharmaceutical Products Microbial Testing

BACKGROUND:

Non-sterile pharmaceutical products are required to meet specific guidelines regulated by the Australian Therapeutic Goods Administration (TGA) under a specific Therapeutic Goods Order. 

Therapeutic Goods Order No.77 Microbiological standards for medicines (TGO 77) was the previous order that was doing this. It had been in force since 1 January 2010. It was automatically repealed (sunset) on 1 October 2018 in accordance with the Legislative Instruments Act 2003. A new instrument, Therapeutic Goods Order No.98 Microbiological Standards for Medicines 2018 (TGO 98) succeeded TGO 77 on this date to provide continuing clarity on the requirements for microbiological quality of medicines.


This order requires medicines to comply with the harmonized methods of microbiological quality of non-sterile products: microbial enumeration tests as well as the harmonized method for specified micro-organisms.  The Australian TGA has taken the view that specified organisms should include Pseudomonads rather than just Pseudomonas aeruginosa.

 

PRINCIPLE OF TEST:

For the total aerobic microbial count and yeast and mould count the product is diluted with a validated neutralizing diluent.  This inactivates any preservatives or inhibitory substances present. The product is then tested by pour plate, spread plate or membrane filtration method.

Testing of objectionable / indicator organisms is performed by an enrichment process.  The product is suitably diluted and enriched by direct broth enrichment or membrane filtration.  The enriched product is then streaked onto various selective agar plates to isolate Bile-tolerant Gram negative bacteria, Gram negative bacteria, Staphylococcus spp,PseudomonadsSalmonella spp and Coliforms.

A confirmation process is performed if typical growth is detected by sub-culturing onto selective media agars.  Further identification can also be performed using our phenotypic ID system (MALDI-TOF) or genetic sequencing system (comparison against our Eurofins IDmyk Comparative Sequence Index).

Products are also able to be tested by specific client methods provided we are given clear instructions and/or standard operating procedures are provided. 

METHOD REFERENCE:

  1. European Pharamcopeia Chapter 2.6.13 Internationally Harmonised Chapter.
  2. United States Pharmacopeia (XXIV).
  3. British Pharmacopoeia current Appendix XVI B. Microbiological Examination of Non-sterile Products.



SAMPLE REQUIREMENTS:

Product Validation:  20g or 20ml for each test
Total aerobic, yeast and mould count: 20g or 20ml
Bile-tolerant Gram negative bacteria count: 10g or 10ml
Index organisms: 20g or 20ml
Salmonella: 10g or 10ml
E.coli: 10g or 10ml

Test Protocols
Test Description Method Code Turnaround Time (TAT)
Validation for plate counts & enrichment TMPC-100 5-7 days
Total aerobic count TMPC-101 3-5 days
Yeast and mould count TMPC-102 5-7 days
Bile-tolerant Gram negative bacteria count TMPC-225 4-5 days
S. aureus, coliforms, Pseudomonads (Index organisms) TMPC-103 3-5 days
Salmonella spp.  TMPC-106 3-4 days
E.coli  TMPC-105 3-5 days